Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

FSGS is an immunologic disorder wherein circulating immune proteins cause damage to the kidneys and progressive injury and scarring. Corticosteroid therapy is occasionally, but not nearly universally, successful in reducing proteinuria, and when patients respond, they have a favorable prognosis. The investigators believe that ACTH therapy (H.P. Acthar Gel) can provide a more rapid, well tolerated reduction in glomerular injury.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

• 1. Biopsy proven FSGS

• 2. Ability to consent and complete study evaluations

• 3. Greater than 2g/day of proteinuria

• 4. No contraindications to treatment with corticosteroids or ACTH

• 5. Women of childbearing potential will agree to use effective forms of birth control throughout this study

Exclusion Criteria:

• 1. Known secondary cause of FSGS

• 2. Receiving active immune therapy (within 90 days)

• 3. Pregnancy

• 4. Creatinine >2.5 mg/dl

• 5. Uncontrolled HTN (>180/100mm Hg)

• 6. Diabetes

• 7. Acute or chronic infection

• 8. Severe comorbidity (active coronary, cerebrovascular disease, cancer, psychiatric disease)

• 9. Age < 16, >65 years

• 10. Evidence of untreated tuberculosis (+PPD or Ellispot Gold testing)

• 11. A known contraindication to ACTH. Corticotropin is considered contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin.